ResponsibilitiesIn collaborating with internal stakeholders (i.e. Finance, Project Management, Legal, Quality Assurance), you will be responsible for the performance of our external partners running clinical trials, ensuring appropriate level of vendor relationship management which includes vendor oversight and performance evaluation.Serve as the main contact for outsourcing process and activities for Clinical Development such as study specific vendor proposals, contracts and amendments.Manages the identification and assists in driving the selection process of clinical vendors such as CROs, central labs, IRT, Imaging, ePRO, Safety vendors etc.Review and manage contracting activities for assigned clinical study programs to ensure adherence to the outsourcing strategy, company policy and procedures, as well as other legal and regulatory requirements.Monitor vendor performance against prescribed indicators and metrics; will actively ensure expectations are met internally and externally with regards to budgeting and reporting, invoicing, turnaround times, contractual documentation and approach, payment schedules and other business practices.Develop cost estimates for study scenarios, develop & forecast full study budgets and keep them up-to-date, working closely with each Clinical Program Lead.Work closely with finance to assure the assumptions for studies as well as accrual reporting are aligned between finance and clinical forecasting.Review and track invoices against vendor contracts to ensure accuracy against contracts.

• Involved in clinical trial financial planning from the proposal phase through execution and close out, patterning closely with Clinical Trial Manager(s) to provide end to end clinical financial support.• Liaison between Clinical Operations and the Finance department with regards to providing clinical financial forecast assumptions• Working with functional teams to determine budgets and payment schedules to support the overall scope of work • Working with Contract Managers to ensure that the Clinical Trial Agreements are in place, and upfront fees and site costs are in line with FMV, and captured in the overall Investigator Grant budgets• Vendor managemento Meeting with Clinical teams to determine all outsourcing needs of the studyo Managing request for proposal (RFP) process in determining vendorso Purchase Order (PO) creation• Vendor Invoice Management o Invoice review to ensure proper PO alignmento Ensuring invoice is within SOWo Manage scope creep (PO review) with Clinical leads to ensure that all necessary contract amendments are done timelyo Vendor Performanceo Work with accounts payable (AP) to ensure that all invoices are paid within agreed payment termso Project close-out working with vendors to provide study reconciliations and final invoices• Supports benchmarking, scenario planning, and forecasting for new and ongoing trials• Prepares monthly management reporting, including metrics and root cause analysis including detailed, in-depth variance analysis and commentaries• Monitors and reports on planned vs. actual clinical trial spend and accruals by study and across the portfolio of studies• Support external and internal audits and inspections• Provides monthly financials, forecasts and budgets to Trial / Project teams• Review and understand clinical contract terms and clinical development plans; working with Clinical Operations to mitigate risk and out-of-scope activities

Manages the Sponsor Contracts Management team and activities, which support execution of procedures relating to the budgeting, preparation and management of contract and change order documents and any other associated duties as assigned. Assists senior management in the development, implementation, and maintenance of contracting processes and systems, while accurately capturing and reporting performance metrics on cycle times, quality, and other key performance indicators. Provides training and supervises contracts team. Essential Functions:• Line management responsibilities including professional development, performance appraisals, employee counseling for junior, and management staff, rewarding and disciplining. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill level, and by delegating tasks commensurate with skill level. • Drives the contract and change order process to ensure timely execution and revenue recognition. Ensures that direct reports are meeting standard turnaround and cycle times. Alerts senior management to potential issues with contracts and change orders as necessary corrective action is taken.• Continuously implements improvements to the processes and systems and put into practice. • Reviews contracts and change orders of direct reports to ensure completeness and accuracy, and that corrections are appropriately made and documented. • May take a proactive role in developing relationships with appropriate staff in preferred customer organizations in close collaboration with Business Development.• Prepares information for and leads internal meetings with direct reports. • Presents to Executive Management the status of contract and change orders directly impacting revenue. • Represents Sponsor Contracts Management at Customer meetings and on task forces as required.

• Manages a team of two to five analysts, including mentoring, training, development, and coaching. Hires staff and conducts formal appraisals. Works with Business Development to prioritize work flow for the team.• Oversees timely collection of data for proposal and budget development in response to Request for Proposals. Analyzes proposal text and budget to corporate metrics, client expectations and other benchmarks. Approves accurate bids and proposals that conform to PPD contract requirements and meet client needs; applies quality control procedures to ensure proposals conform to departmental standards. Oversees data gathering and analysis for proposals and contract modifications. Ensures revisions are completed on a timely basis.• Interacts with operations management to make sure that final contract meets their needs, conducting risk assessments and making decisions on production of units and unit prices. Suggests appropriate remedies to minimize operational risk. Work with legal to ensure that PPD’s legal interests are represented in the final contract, minimizing legal risk.• Makes recommendations to senior management regarding gross profit, pricing decisions, payment schedule analysis and volume discount agreements after liaison with Finance.• Attends client meetings to defend PPD proposals prior to project award, negotiate pricing or contracts post-award, or to maintain and improve processes and relationships.• Review and coordinate negotiation and completion of Master Services agreements.• Make recommendations for continuous process improvement within the department.

• Management of a PPD Key Account.• Preparation of complex written proposals and budget estimates in response to Requests for Proposals that produce a high level of customer satisfaction and responsiveness.• Preparation of complicated contract modifications to existing proposals and contracts.• Resolution of complex problems encountered in the proposal and contract process.• Collaboration with Finance personnel to develop payment schedules and Gross Profit analyses that conform to PPD requirements and meet client needs• Allocates new Request for Proposals and contract modifications.• Prioritization of team deliverables.• On-going training and development of Commercial Analyst I and Commercial Analyst IIs• Supervision of three Commercial Analysts.

• Formulate complex, straightforward proposals in conjunction with various Duke Clinical Research Institute (DCRI) functional groups, CROs, Academic Medical Centers, SMOs, and Duke Therapeutic departments.• Evaluate project performance to refine and improve all components of proposals.• Track and report on the status of all proposal components.• Establish and maintain on-going client relationships with various parties to anticipate and resolve potential problems.• Research, identify and pursue appropriate opportunities for additional business with existing sponsors.• Draft and monitor annual Strategic Plans on non-commercial or industry sponsor activities to be provided to Chief Strategy Officer.• Initiate significant sponsor meetings and make a major contribution to the contract negotiation process.• Introduce and develop new proposal tools, processes and activities.• Mentor other junior Business Development Associates at DCRI on non-commercial or industry sponsored projects and the associated processes.• Display a solid understanding of the DCRI mission in addition to understanding what an ARO represents.• Assist Director in the management functions of the team.

• Developed proposal strategies.• Managed a team of Proposal Associates and Proposal Developers based on sponsor assignments.• Supervised the proposal development process for Proposal Associates and Proposal Developers.• Solicited input from operations team.• Conducted resourcing calls with potential clients. • Reviewed all proposal text and budgets.• Participated in the presentation and justification of the budget.• Attended pre-meetings with potential clients.• Assisted Sales, Finance, and Project Management in the review of on-going projects for scope changes and budget issues. • Trained Proposal Developers and Proposal Associates in the process of developing proposals and preparing scopes-of-work and budgets.

• Determined the scope-of-work for all Request for Proposals (RFPs).• Developed all types of budgets. • Interacted with Business Development, ClinTrial’s personnel, and major pharmaceutical companies.• Provided extensive teamwork with the Proposal Associate writing the verbiage to design winning bids. • Used Lotus 123 to compile all budgets. • Supplied cost and financial analysis to sponsors as necessary. • Generated budgets ranging from $500,000 - $50,000,000.

• Maintained company’s business relationship with existing clients as assigned.• Developed and executed account plans with the objective of maintaining total client satisfaction.• Presented expert interpretation of data contained in CMS reports and processes.• Provided improvement recommendations to clients.• Made strategic recommendations by applying knowledge of coupon industry and competitors’ services. • Analyzed client operations and performed financial analysis for appropriate situations.• Interfaced with other CMS departments to identify and troubleshoot client problems.• Performed marketing and misredemption analysis as necessary.• Facilitated communication with relevant parties. • Analyzed computer data. • Developed and presented key client reviews and presentations containing actionable information and strategic recommendations based on knowledge of clients’ marketing strategy.• Served as internal expert to co-workers in CMS systems and services through extensive knowledge of all facets of CMS computer system functions and files.• Collaborated with the CMS Information Technology Department to develop and enhance new products and marketing tools.• Joined forces with the CMS Marketing and Brand Services Department to develop appropriate presentations.